Acute Leukemia in RemissionPhase 2NCT01488253
Sirolimus/Tacrolimus Combination After HLA Matched Related Peripheral Blood Stem Cell Transplants
A Phase 2 study testing Sirolimus and Tacrolimus in people with Acute Leukemia in Remission and Myelodysplastic Syndromes, run by The Korean Society of Blood and Marrow Transplantation at 1 site in South Korea.
Trial summary
Study Design: To evaluate the efficacy of the combination of sirolimus and tacrolimus as a graft-versus-host disease prophylaxis, the investigators are going to perform a phase II, multicenter clinical trial after human leukocyte antigen (HLA)-matched, related peripheral blood stem cell transplants (PBSCT) in patients… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Acute Leukemia in Remission, Myelodysplastic Syndromes, Leukemia, Myeloid, Chronic-Phase
- What is being tested?
- Sirolimus and Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to provide written informed consent prior to participating to the study
- Patients with acute leukemia in remission, MDS, and CML in chronic \& accelerated phase
- Patients with HLA identical donor, a serologic (or higher resolution) 6/6 Class I HLA-A and B and molecular Class II DRB1 must be matched.
- Patients with an ECOG performance status score < 2
- Adequate end organ functions as defined by: Total bilirubin < 1.5 × ULN, AST and ALT < 2.5 × ULN, Creatinine < 1.5 × ULN.
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before initiation of study drug.
Who cannot join
- Acute promyelocytic leukemia (M3)
- Patients with another primary malignancy other than hematologic disease
- Patients with a severe or uncontrolled medical condition (i.e. uncontrolled diabetes, chronic renal disease)
- Patients who are ① pregnancy, ② breast feeding, ③ of childbearing potential without a negative pregnancy test prior to baseline and ④ male or female of childbearing potential unwilling to use barrier contraceptive precautious throughout the trial (post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential)
- Patients with an ECOG performance status score ≥ 2
- Patients with known positivity for HIV; baseline testing for HIV is not required
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767
About this study
Official title: Multicenter Trials to Evaluate the Efficacy and Toxicity of Sirolimus/Tacrolimus Combination as a GVHD Prophylaxis After HLA Matched Related PBSCT
Study Design: To evaluate the efficacy of the combination of sirolimus and tacrolimus as a graft-versus-host disease prophylaxis, the investigators are going to perform a phase II, multicenter clinical trial after human leukocyte antigen (HLA)-matched, related peripheral blood stem cell transplants (PBSCT) in patients with hematologic malignancies. Total 116 patients will be accrued.
Objective: The primary objective is to evaluate the rates of 100 day Grade II-IV acute GVHD. Secondary objectives include the time to neutrophil and platelet engraftment, the incidence of grade III-IV acute GVHD, non-relapse mortality during 100 days after transplant, mucositis severity, all infectious complications including cytomegalovirus (CMV) reactivation, vascular complications (venoocclusive disease of liver; VOD, thrombotic microangiopathy; TMA), disease-free survival, and overall survival at 1 year after transplant.
Read more
Eligibility Criteria: Eligible patients are between 20 and 60 years of age, have acute leukemia, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and adequate organ function. For available sibling donor, a serologic (or higher resolution) 6/6 Class I HLA-A and B and molecular Class II DRB1 must be matched.
Treatment Description: Conditioning regimens will vary by center and donor will donate peripheral blood stem cells according to local institutional practices. Peripheral blood stem cells will not be manipulated or T-depleted prior to infusion. Tacrolimus will be administered at 0.05 mg/kg/day intravenously by continuous infusion beginning on day -1 with a target serum concentration of 5 to 10 ng/mL. Sirolimus will be administered as a 6 mg oral loading dose on day -1, followed by a 3 mg/day single dose, with a target serum concentration of 3 to 12 ng/mL. Levels will be monitored weekly during hospitalization and then as clinically indicated. Intravenous tacrolimus will be converted to an oral equivalent dose prior to discharge and both immunosuppressives will be tapered beginning at day +100 after transplantation and eliminated by day +180 when clinically feasible.
Accrual Period: The estimated accrual period is three years. Patients will be followed for 100 days post transplantation for evaluation of the primary endpoint, with additional follow-up to two years after transplantation for evaluation of secondary endpoints.
Read the detailed description
Rationale: Graft-versus-host disease (GVHD) remains a major cause of morbidity and mortality after allogeneic HSCT. The combination of a calcineurin inhibitor and methotrexate has been the standard GVHD prophylactic regimen for the past 20 years. However, the incidence of acute GVHD remains high, with reported cumulative incidence of grade II-IV up to 60%. Serious acute GVHD or chronic GVHD has detrimental consequences in patients including death, disability, infections, or prolonged hospitalization.
Sirolimus is the first available inhibitor of the mammalian target of rapamycin (mTOR). And sirolimus binds uniquely to FK-binding protein (FKBP12) and forms a complex with mTOR. This complex inhibits several biochemical pathways, resulting in a reduction in DNA transcription, DNA translation, protein synthesis, and cell cycling, ultimately leading to T-cell immunosuppression. Sirolimus has been used alone and in combination with calcineurin inhibitors for prevention of allograft rejection after solid organ transplantation. In the field of hematopoietic stem cell transplantation, the combination of sirolimus and tacrolimus has also resulted in a low incidence of acute GVHD and reduced transplant-related toxicity.
In addition, the investigators demonstrated previously that the combination of tacrolimus and sirolimus is effective as a GVHD prophylaxis and well tolerated in cases of high risk transplantation using mismatched related or unrelated donor.
As discussed above, sirolimus has emerged as one of the most promising immunosuppressive agents in allogeneic hematopoietic stem cell transplantation. However, the benefit of GVHD prophylaxis regimens including sirolimus has not been confirmed consistently and there is controversy that the incorporation of sirolimus into GVHD prophylaxis results in improved survival.
Efficacy measures: Patients will be followed for 100 days post transplantation for evaluation of the primary endpoint (the incidence and severity of acute GVHD) and clinical data will be collected at 100 day after HSCT using case report form. And patients will be recommended additional follow-up to one year after HSCT for evaluation of secondary endpoints or parameters including clinical outcomes (disease-free survival and overall at 1 year after transplant). The investigators will perform the interim analyses at the time when 31 patients are enrolled during phase 1.
Acute GVHD will be graded according to the consensus grading scale (appendix-1). The broad category of acute GVHD includes:
- Classic acute GVHD (maculopapular rash, nausea, vomiting, anorexia, profuse diarrhea, illus, or cholestatic hepatitis) occurring within 100 days after transplantation (without diagnostic or distinctive signs of chronic GVHD)
- Persistent, recurrent, or late acute GVHD: Features of classic acute GVHD without diagnostic or distinctive manifestations of chronic GVHD occurring beyond 100 days of transplantation (often seen after withdrawal of immune suppression).
Safety: All the safety analyses will be based on safety population. The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of predetermined ranges. Adverse events will be summarized by presenting the number and percentage of patients having any adverse event as well as by severity to study treatment. In addition the summary of grade 3 and 4 will be presented.
During administration of drugs as a GVHD prophylaxis, toxicities related to drugs will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Patients will also be assessed regularly by physical examination and laboratory tests including CBC, biochemistry including liver function test and chest X-ray.
Statistical Methods: Descriptive statistical analysis will be performed to assess patient baseline characteristics, engraftment, acute GVHD, and non-relapse mortality. Overall survival and relapse-free survival will be calculated using the Kaplan-Meier method and estimated using a competing risk of 100-day mortality for cumulative incidence rate of grades II-IV acute GVHD.
- Conditions
- Acute Leukemia in Remission, Myelodysplastic Syndromes, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myeloid, Accelerated-Phase
- Being tested
- Sirolimus, Tacrolimus
- Keywords
- Hematopoietic stem cell transplantation, Graft vs Host disease, Prevention, Sirolimus, Tacrolimus
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myeloid, Accelerated Phase, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called Rapamune (sirolimus, rapamycin)
Sirolimus will be administered as a 6-mg oral loading dose beginning on day -1, followed by 3 mg per day orally in a single morning dose with a target trough level of 5-12 ng/mL. Trough levels will be measured once a week. Sirolimus will be gradually tapered beginning at day +100, and eliminated by day +180, unless the patient required continued treatment for GVHD or experienced toxicity related to drugs.
TacrolimusDrug
Also called Prograf (tacrolimus)
Tacrolimus will be administered beginning on day -1 at 0.05 mg/kg intravenously by continuous infusion every 24 hours, with a target serum level of 5 to 10 ng/mL. Tacrolimus dosing is converted to oral capsules prior to discharge. Trough levels will be measured once a week. Tacrolimus will be gradually tapered beginning at day +100, and eliminated by day +180, unless the patient required continued treatment for GVHD or experienced toxicity related to drugs.
| Study group | Role | What they receive |
|---|---|---|
| acute GVHD prevention by sirolimus based regimen | Experimental | The investigators will evaluated the primary endpoint and secondary endpoints comparing with historical control, that is used tacrolimus/methotrexate as a GVHD prophylaxis after HLA-matched, related PBSCT. Receives: Drug: Sirolimus; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of grade II-IV acute graft-versus host disease
Patients will be followed for 100 days post transplantation for evaluation of the primary endpoint (the incidence and severity of acute GVHD) and clinical data will be collected at 100 day after HSCT using case report form. Acute GVHD will be graded according to the consensus grading scale.
Measured: 100 days after allogeneic HSCT
Secondary outcomes (7)
The time to neutrophil and platelet engraftment
The time of engraftment is defined as the first of three consecutive days on which the absolute neutrophil counts exceed 0.5 X 10(9)/L and platelet count to 20 X 10(9)/L, respectively.
Measured: within 6 weeks after transplant
The incidence of grade III-IV acute GVHD
Acute GVHD will be graded according to the consensus grading scale.
Measured: During 100 days after transplant
Non-relapse mortality
All deaths without relapse or progression of underlying disease
Measured: During 100 days after transplant
Mucositis severity
It will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0).
Measured: 100 days after transplant
All infectious complications including CMV reactivation
The incidence and type of infectious complications
Measured: 100 days after transplant
Vascular complications
The incidence of venoocclusive disease of liver and syndrome of thrombotic microangiopathy.
Measured: 100 days after transplant
Clinical outcome at 1 year after transplant
Disease-free survival and overall survival at 1 year after transplant
Measured: 1 year after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2013
- Study completionOct 2014
Why it stopped: We could not receive the support from the national medical insurance owing to the changed policy of the government for clincal trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Leukemia in RemissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Korean Society of Blood and Marrow Transplantation
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Chonbuk National University Hospital, Chonnam National University Hospital, Chung-Ang University Hospital, Daegu Catholic University Medical Center, Ewha Womans University Mokdong Hospital, Gachon University Gil Medical Center, Inha University Hospital, Inje University, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Pusan National University Hospital, Samsung Medical Center, Severance Hospital, Seoul St. Mary's Hospital, Seoul National University Hospital, Soonchunhyang University Hospital
- Responsible party
- Principal investigator, Seong Kyu Park, MD, The Korean Society of Blood and Marrow Transplantation
- Investigators
- Seong Kyu Park, MD, PhD, Principal investigator, Clinical Trials Committee of The Korean Society of Blood and Marrow Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488253
- Sponsor's protocol ID
- KSBMT2011-01
- Status last verified
- Mar 2015
- First submitted
- 20 Nov 2011
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trials to Evaluate the Efficacy and Toxicity of Sirolimus/Tacrolimus Combination as a GVHD Prophylaxis After HLA Matched Related PBSCT
- ClinicalTrials.gov ID
- NCT01488253
- Acronym / sponsor ID
- KSBMT2011-01
- Conditions
- Acute Leukemia in Remission, Myelodysplastic Syndromes, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myeloid, Accelerated-Phase
- Keywords
- Hematopoietic stem cell transplantation, Graft vs Host disease, Prevention, Sirolimus, Tacrolimus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We could not receive the support from the national medical insurance owing to the changed policy of the government for clincal trials.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Korean Society of Blood and Marrow TransplantationUniversity, hospital or other
- Collaborators
- Asan Medical Center, Chonbuk National University Hospital, Chonnam National University Hospital, Chung-Ang University Hospital, Daegu Catholic University Medical Center, Ewha Womans University Mokdong Hospital, Gachon University Gil Medical Center, Inha University Hospital, Inje University, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Pusan National University Hospital, Samsung Medical Center, Severance Hospital, Seoul St. Mary's Hospital, Seoul National University Hospital, Soonchunhyang University Hospital
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Design: To evaluate the efficacy of the combination of sirolimus and tacrolimus as a graft-versus-host disease prophylaxis, the investigators are going to perform a phase II, multicenter clinical trial after human leukocyte antigen (HLA)-matched, related peripheral blood stem cell transplants (PBSCT) in patients with hematologic malignancies. Total 116 patients will be accrued.
Objective: The primary objective is to evaluate the rates of 100 day Grade II-IV acute GVHD. Secondary objectives include the time to neutrophil and platelet engraftment, the incidence of grade III-IV acute GVHD, non-relapse mortality during 100 days after transplant, mucositis severity, all infectious complications including cytomegalovirus (CMV) reactivation, vascular complications (venoocclusive disease of liver; VOD, thrombotic microangiopathy; TMA), disease-free survival, and overall survival at 1 year after transplant.
Eligibility Criteria: Eligible patients are between 20 and 60 years of age, have acute leukemia, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and adequate organ function. For available sibling donor, a serologic (or higher resolution) 6/6 Class I HLA-A and B and molecular Class II DRB1 must be matched.
Treatment Description: Conditioning regimens will vary by center and donor will donate peripheral blood stem cells according to local institutional practices. Peripheral blood stem cells will not be manipulated or T-depleted prior to infusion. Tacrolimus will be administered at 0.05 mg/kg/day intravenously by continuous infusion beginning on day -1 with a target serum concentration of 5 to 10 ng/mL. Sirolimus will be administered as a 6 mg oral loading dose on day -1, followed by a 3 mg/day single dose, with a target serum concentration of 3 to 12 ng/mL. Levels will be monitored weekly during hospitalization and then as clinically indicated. Intravenous tacrolimus will be converted to an oral equivalent dose prior to discharge and both immunosuppressives will be tapered beginning at day +100 after transplantation and eliminated by day +180 when clinically feasible.
Accrual Period: The estimated accrual period is three years. Patients will be followed for 100 days post transplantation for evaluation of the primary endpoint, with additional follow-up to two years after transplantation for evaluation of secondary endpoints.
Detailed description
Rationale: Graft-versus-host disease (GVHD) remains a major cause of morbidity and mortality after allogeneic HSCT. The combination of a calcineurin inhibitor and methotrexate has been the standard GVHD prophylactic regimen for the past 20 years. However, the incidence of acute GVHD remains high, with reported cumulative incidence of grade II-IV up to 60%. Serious acute GVHD or chronic GVHD has detrimental consequences in patients including death, disability, infections, or prolonged hospitalization.
Sirolimus is the first available inhibitor of the mammalian target of rapamycin (mTOR). And sirolimus binds uniquely to FK-binding protein (FKBP12) and forms a complex with mTOR. This complex inhibits several biochemical pathways, resulting in a reduction in DNA transcription, DNA translation, protein synthesis, and cell cycling, ultimately leading to T-cell immunosuppression. Sirolimus has been used alone and in combination with calcineurin inhibitors for prevention of allograft rejection after solid organ transplantation. In the field of hematopoietic stem cell transplantation, the combination of sirolimus and tacrolimus has also resulted in a low incidence of acute GVHD and reduced transplant-related toxicity.
In addition, the investigators demonstrated previously that the combination of tacrolimus and sirolimus is effective as a GVHD prophylaxis and well tolerated in cases of high risk transplantation using mismatched related or unrelated donor.
As discussed above, sirolimus has emerged as one of the most promising immunosuppressive agents in allogeneic hematopoietic stem cell transplantation. However, the benefit of GVHD prophylaxis regimens including sirolimus has not been confirmed consistently and there is controversy that the incorporation of sirolimus into GVHD prophylaxis results in improved survival.
Efficacy measures: Patients will be followed for 100 days post transplantation for evaluation of the primary endpoint (the incidence and severity of acute GVHD) and clinical data will be collected at 100 day after HSCT using case report form. And patients will be recommended additional follow-up to one year after HSCT for evaluation of secondary endpoints or parameters including clinical outcomes (disease-free survival and overall at 1 year after transplant). The investigators will perform the interim analyses at the time when 31 patients are enrolled during phase 1.
Acute GVHD will be graded according to the consensus grading scale (appendix-1). The broad category of acute GVHD includes:
- Classic acute GVHD (maculopapular rash, nausea, vomiting, anorexia, profuse diarrhea, illus, or cholestatic hepatitis) occurring within 100 days after transplantation (without diagnostic or distinctive signs of chronic GVHD)
- Persistent, recurrent, or late acute GVHD: Features of classic acute GVHD without diagnostic or distinctive manifestations of chronic GVHD occurring beyond 100 days of transplantation (often seen after withdrawal of immune suppression).
Safety: All the safety analyses will be based on safety population. The assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of predetermined ranges. Adverse events will be summarized by presenting the number and percentage of patients having any adverse event as well as by severity to study treatment. In addition the summary of grade 3 and 4 will be presented.
During administration of drugs as a GVHD prophylaxis, toxicities related to drugs will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Patients will also be assessed regularly by physical examination and laboratory tests including CBC, biochemistry including liver function test and chest X-ray.
Statistical Methods: Descriptive statistical analysis will be performed to assess patient baseline characteristics, engraftment, acute GVHD, and non-relapse mortality. Overall survival and relapse-free survival will be calculated using the Kaplan-Meier method and estimated using a competing risk of 100-day mortality for cumulative incidence rate of grades II-IV acute GVHD.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute GVHD prevention by sirolimus based regimen | Experimental | Drug: Sirolimus, Drug: TacrolimusThe investigators will evaluated the primary endpoint and secondary endpoints comparing with historical control, that is used tacrolimus/methotrexate as a GVHD prophylaxis after HLA-matched, related PBSCT. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to provide written informed consent prior to participating to the study
- Patients with acute leukemia in remission, MDS, and CML in chronic \& accelerated phase
- Patients with HLA identical donor, a serologic (or higher resolution) 6/6 Class I HLA-A and B and molecular Class II DRB1 must be matched.
- Patients with an ECOG performance status score < 2
- Adequate end organ functions as defined by: Total bilirubin < 1.5 × ULN, AST and ALT < 2.5 × ULN, Creatinine < 1.5 × ULN.
Key exclusion criteria (6 listed)
- Acute promyelocytic leukemia (M3)
- Patients with another primary malignancy other than hematologic disease
- Patients with a severe or uncontrolled medical condition (i.e. uncontrolled diabetes, chronic renal disease)
- Patients who are ① pregnancy, ② breast feeding, ③ of childbearing potential without a negative pregnancy test prior to baseline and ④ male or female of childbearing potential unwilling to use barrier contraceptive precautious throughout the trial (post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential)
- Patients with an ECOG performance status score ≥ 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SirolimusAlso: Rapamune (sirolimus, rapamycin)Sirolimus will be administered as a 6-mg oral loading dose beginning on day -1, followed by 3 mg per day orally in a single morning dose with a target trough level of 5-12 ng/mL. Trough levels will be measured once a week. Sirolimus will be gradually tapered beginning at day +100, and eliminated by day +180, unless the patient required continued treatment for GVHD or experienced toxicity related to drugs. | Drug | acute GVHD prevention by sirolimus based regimen |
| TacrolimusAlso: Prograf (tacrolimus)Tacrolimus will be administered beginning on day -1 at 0.05 mg/kg intravenously by continuous infusion every 24 hours, with a target serum level of 5 to 10 ng/mL. Tacrolimus dosing is converted to oral capsules prior to discharge. Trough levels will be measured once a week. Tacrolimus will be gradually tapered beginning at day +100, and eliminated by day +180, unless the patient required continued treatment for GVHD or experienced toxicity related to drugs. | Drug | acute GVHD prevention by sirolimus based regimen |
Primary outcome
The rate of grade II-IV acute graft-versus host disease
Time frame: 100 days after allogeneic HSCT
Patients will be followed for 100 days post transplantation for evaluation of the primary endpoint (the incidence and severity of acute GVHD) and clinical data will be collected at 100 day after HSCT using case report form. Acute GVHD will be graded according to the consensus grading scale.
7 secondary outcomes
The time to neutrophil and platelet engraftment
Time frame: within 6 weeks after transplant
The incidence of grade III-IV acute GVHD
Time frame: During 100 days after transplant
Non-relapse mortality
Time frame: During 100 days after transplant
Mucositis severity
Time frame: 100 days after transplant
All infectious complications including CMV reactivation
Time frame: 100 days after transplant
Vascular complications
Time frame: 100 days after transplant
Clinical outcome at 1 year after transplant
Time frame: 1 year after transplant
Results and safety
The study was stopped early (reason given: We could not receive the support from the national medical insurance owing to the changed policy of the government for clincal trials.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seong Kyu Park, MD, PhD principal investigator
Clinical Trials Committee of The Korean Society of Blood and Marrow Transplantation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sirolimus and Tacrolimus in people with Acute Leukemia in Remission and Myelodysplastic Syndromes, run by The Korean Society of Blood and Marrow Transplantation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: We could not receive the support from the national medical insurance owing to the changed policy of the government for clincal trials.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of grade II-IV acute graft-versus host disease (time frame: 100 days after allogeneic HSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.